Strengths: Real world trial, Good generalizability, Largest sample size yet for this type of study, Clinically significant: remission as the primary outcomeWeaknesses: No control, Nonmasked treatment delivery, Small sample.

Validity Crtieria

Was follow up adequate? YesWere the participants randomized? YesWas allocation concealed? N/AIntention to treat? YesWere the groups similar at baseline? YesWere pts, MDs and analysts blinded? NoWere the groups treated equally? YesWas there an a priori hypothesis? YesWere the outcome clearly defined? YesDid they use validated measurements? YesWas the placebo/control appropriate? N/AWere side effects discussed? YesIs the effect clinically important? YesIs this congruent with existing studies? NoIs this feasible in your setting? YesWere the investigators independent? +/-Will this change your current practice? No